Remote: Sr. Regulatory Affairs Position (232416)

Life Sciences & Technology

Job Description 

Our Client is looking for a Senior Regulatory Affairs Specialist with 8+ years of industry experience and 6+ years focused within EU MDR. This individual will serve as the primary regulatory representative on Product Engineering and Manufacturing teams. The main responsibilities include performing Medical Device Regulations (MDR) regulatory assessments to determine the gaps and impact on design/process/products, technical file updates, creation of Summary Technical Documentation (STED), preparing regulatory submissions, maintaining regulatory filings and licenses, design input/output documentation, identification of applicable standards and guidance documents, and interacting with regulatory agencies as needed. This professional needs to have extensive experience preparing and submitting regulatory filings for the above markets including IDEs, 510(k)s, non-filing justifications, Technical File creation/updates, Canadian License Applications

Required Skills 

Regulatory Affairs
Gap Assessments
IDE / 510k Submissions
Project Management Skills
STED Template Creation – PLUS
Regulatory Intelligence exp – PLUS

Remote: Sr. Regulatory Affairs Position (232416)


About Black Diamond Networks
Black Diamond Networks delivers talent uplifted. We deploy highly skilled consultants to support quality, compliance, and innovation in regulated industries and beyond. Black Diamond’s delivery model is wired for speed and precision, due to a cultivated community of experts in life sciences, engineering, and technology. Raise your expectations for dynamic solutions.

Black Diamond Networks is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.

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